Catalog Number

-

Brand Name

Heff Med

Version/Model Number

HM-D840

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

a27e3535-3dfa-4183-97bb-06fbd6a81070

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

June 18, 2019

Package DI Number

10850003355389

Quantity per Package

60

Contains DI Package

00850003355382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case